A disease which is long lasting or which reoccurs often is defined typically as a chronic disease. Known chronic diseases include, among others, depression, compulsive obsession disorder, alcoholism, asthma, autoimmune diseases (e.g., ulcerative colitis, lupus erythematosus), osteoporosis, cancer, and diabetes mellitus. Such chronic diseases require chronic care management for effective long-term treatment. After an initial diagnosis, one of the functions of chronic care management is then to optimize a patient's therapy of the chronic disease.
In the example of diabetes mellitus, which is characterized by hyperglycemia resulting from inadequate insulin secretion, insulin action, or both, it is known that diabetes manifests itself differently in each person because of each person's unique physiology that interacts with variable health and lifestyle factors such as diet, weight, stress, illness, sleep, exercise, and medication intake.
Biomarkers are patient biologically derived indicators of biological or pathogenic processes, pharmacologic responses, events or conditions (e.g., aging, disease or illness risk, presence or progression, etc.). For example, a biomarker can be an objective measurement of a variable related to a disease, which may serve as an indicator or predictor of that disease. In the case of diabetes mellitus, such biomarkers include measured values for glucose, lipids, triglycerides, and the like. A biomarker can also be a set of parameters from which to infer the presence or risk of a disease, rather than a measured value of the disease itself. When properly collected and evaluated, biomarkers can provide useful information related to a medical question about the patient, as well as be used as part of a medical assessment, as a medical control, and/or for medical optimization.
For diabetes, clinicians generally treat diabetic persons according to published therapeutic guidelines such as, for example, Joslin Diabetes Center & Joslin Clinic, Clinical Guideline for Pharmacological Management of Type 2 Diabetes (2007) and Joslin Diabetes Center & Joslin Clinic, Clinical Guideline for Adults with Diabetes (2008). The guidelines may specify a desired biomarker value, e.g., a fasting blood glucose value of less than 100 mg/dl, or the clinician can specify a desired biomarker value based on the clinician's training and experience in treating patients with diabetes.
However, such guidelines do not specify biomarker collection procedures for parameter adjustments to support specific therapies used in optimizing a diabetic person's therapy. Subsequently, diabetic persons often must measure their glucose levels with little structure for collection and with little regard to lifestyle factors. Specifically, a host of issues have been identified for the titration of basal insulin. The root cause of these issues is a lack of a centralized location that tells the patient the specific dosage of insulin to take—both during the titration optimization phase, as well as post optimization—daily use. The issues may include the following: patients taking only the amount on the label attached to the packaging as originally prescribed by the physician; patients eating before sampling their blood glucose rendering the sample instance unusable or inappropriate; patients forgetting to take the samples at the appropriate time; patients refusing to take more than the minimal amount due to fear; and not understanding the instructions from the physician.
It is desirable to include a parameterized testing method for the implementation of most known basal rate titration algorithms, permitting the creation of structured centralized testing procedures to assist the patient in insulin titration.